Save Job Back to Search Job Description Summary Similar JobsLead risk management and design quality across product development.Ensure compliant, risk-informed product delivery across teams.About Our ClientOur client is an innovative medical device organization operating in a highly regulated global environment. They specialize in developing advanced technologies while maintaining strict compliance with international quality and regulatory standards, including ISO 13485, ISO 14971, and FDA requirements. Their culture emphasizes cross-functional collaboration, technical excellence, and proactive risk management throughout the product lifecycle.Job DescriptionServe as the risk management lead and SME, ensuring full lifecycle execution of risk processes in alignment with ISO 14971Coordinate design control activities while ensuring risk is properly integrated at every phase of product developmentLead risk assessments, author risk management plans and reports, and facilitate cross-functional risk reviewsOwn and maintain all product risk documentation, ensuring accuracy, completeness, and audit readinessEnsure Design History Files (DHF) are complete with properly documented and traceable risk elementsCollaborate with Regulatory, Product Development, and Clinical teams to ensure global standards and risk considerations are fully addressedManage post-market risk activities, including complaint trending, signal detection, and updates to risk filesReview and approve internal and external Engineering Change Orders (ECOs), ensuring appropriate risk evaluationSupport Device Master Record (DMR) and technical dossier development with a focus on risk and compliance alignmentLead investigations into non-conformances, complaints, and CAPAs, ensuring risk impacts are assessed and addressedReview validation protocols and reports to ensure GMP compliance and alignment with risk-based approachesSupport internal audits and ongoing Quality Management System (QMS) improvementsProvide training and guidance on risk management principles, design controls, and quality system processesMaintain deep knowledge of global standards including ISO 13485, ISO 14971, FDA 21 CFR Part 820/812, MDR, and MDSAPMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Successful ApplicantBachelor's degree in Electrical Engineering10+ years of experience in the medical device or regulated industryStrong expertise in risk management (ISO 14971), with working knowledge of design controlsExperience supporting product development in a regulated environmentKnowledge of global quality and regulatory standards (ISO 13485, FDA 21 CFR Part 820, MDR, MDSAP)Experience with post-market surveillance, complaint handling, and risk trending preferredStrong analytical, problem-solving, and root cause investigation skillsExcellent technical writing and documentation capabilitiesAbility to manage multiple projects and work independentlyStrong communication and cross-functional collaboration skillsWhat's on OfferCompetitive salary with strong growth potential in a specialized quality roleComprehensive benefits package (medical, dental, vision, etc.)Opportunity to own and drive risk management strategy within innovative medical device developmentExposure to cross-functional teams and global regulatory environmentsAbility to directly influence product safety, compliance, and continuous improvementContactAlexander TveterQuote job refJN-062026-7037236Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationPhiladelphiaContract TypePermanentConsultant nameAlexander TveterJob ReferenceJN-062026-7037236
